Welcome to Farmer Talk Radio. This podcast is focused on balancing between concentration and volume when developing patient centric biologics from the twenty twenty four our pod Partnership Opportunities in Drug Delivery Conference. For more information on the pod conference, editorials, podcasts, or webcasts, please visit Drug desh Delivery dot org. Thank you and enjoy the podcast.
Okay, so, welcome to this panel session. I'm Christian Jones, chief commercial officer at Naniform, and I'm a patient. Well, I guess we all are right in this room, and to me, patient centricity is about providing options to patients. We don't always know what we want though as people, so necessarily we don't necessarily know what a patient centric medicine should look like, but it means very different things depending on whether we're talking about chronic.
Disease or acute illnesses.
Today we're going to talk about patient centricity, but with the perspective of high concentration formulations versus higher volume drug delivery for biologics. I'm going to start off with this slide and I'd just like to talk about how payers view patient centricity. I think this is quite a nice example of remickaide from J ANDJ. You can see that in the EU five markets the biosimilar took seventy two percent of the of the dollar share and fifty one
percent in the US. But as the patient centric form came forward in a subcutaneous injection, that took a rapid share of the market up to twenty seven percent already, and it'd be fascinating to see what happens as that was recently launched in the US moving forward if we go to the next slide. So this is a bit of a complex slide, and if you want to a little bit more detail about what this actually means, come
and talk to me afterwards at Naniform booth. But we analyzed all of the exclusivity public relationships around high concentration formulations in subcutaneous monoclonal antibody delivery, and you can see here that the race is on to try to lock in exclusivity around certain technologies in this space with the
colored bars representing different solution providers. But you know, one technology isn't always the answer for one target, and there are even examples there's one company that's actually locked in two different technologies for the same target, but it's a very very complicated space, but people are really trying to
develop the most patient centric forms by accessing innovation. And with that, I'd like to move on to the discussion today, and I'd like my panelists here to introduce themselves and also to say what they believe patient centricity means to them.
So perhaps we could start with Nick.
Sure, Thanks Christian, So I'm mixed Schill. I head up the product.
Development and commercialization team at Kaimanox, which is a life science services provider, So I would say the definition of patient centricity is pretty straightforward, but I think it starts with asking a few questions around understanding the disease journey of a particular patient population and such questions you may ask if you're developing a product, is what is the existing standard of care, what is it not getting right,
what unmet need needs to be filled? And where Honestly, if you were a patient, would you actually want to use this product? And to me, that's kind of the most important question to ask, because I've encountered some products in.
My career thus far that I don't know who created.
This, but they obviously didn't think about who was going to use it, and that is a very difficult scenario to be in if you're a patient.
Now, don't get me wrong, novel therapeutics should get the market as quickly as possible.
Right If there is truly an unmet need in that space, we need to get a new therapy as quickly as possible. However, it needs to at least be usable. Maybe not patient centric to a t, but at least usable. Thanks Nick, Lindsey, Yeah, thank you.
I'm Lindsay Crawford. I am in drug product development at Vizor, and to me, patient centricity is keeping in mind the patient through all those phases of development, remembering them from the beginning all the way through that commercial product, and it's thinking about what would be best for the administration of the product, but also what's going to give them the lifestyle that they deserve to have while they're taking this treatment. How can they travel, how can they live
their normal life? What will make the best for them?
Super thanks and Danny.
Hello, Daniel, just say I lead the early engagement or the vice ability team at GSK, part of the packaging design and the vice solutions. To me, patients interest is really engaging early with our discovery colleagues. Again, working with the right target product profile to make sure that we understand that the patient needs bringing some early formative human factor study, not waiting till before phase three to start
thinking about what the device should be. So really the early engagement is patient centric super.
My name is Egan.
I'm head of injection systems for Taketa, So patient centricity for me, in general, I think it is some deep understanding of the patient population, user, user conditions and use conditions and if this is in general term conditions contacts
of developing a UH drug product delivery solutions. But if I can be laser focused on these bio logic development and I would say in this case is the the you know, high performance challenges associated with these high volume, high viscusity discussion formulation.
Thanks very much.
Okay, So moving to sort of the first question for the panel, and I'd like to just ask e and Lindsey what do you consider as the current state of the art today when we think about injectable biologics and what are the limitations from a formulation and a device perspective.
Maybe if you could you could.
Start sure I can, I can pick it off and feel free to jump in and add so these when me talk about this, you know, particular on the volume and balancing the constitution and volume. You know, maybe we first immediately jump into the liquid formulation, but keep in mind many of these biologic products are still in the solid those forms. So the there are you know, available many available options for reconstitution and of these uh solid
form and those kind of devices. But primary containers most likely to be like a wiles and the you know, the delivery devices will be a syringe or so. These kind of like A configurations provided the most flexibility in terms of delivering high high volume and vi viscus UH product. However, the limit, the limitation is the usability for uh self
inject injection of care. This is most likely to be like at the clinic setting, so and a little bit more convenience to the to the users UH will be the you know those for uh the deal chamber uh syringes or chamber cartridges. So this uh you know, this kind of a device. Primary container can can be integrated with a few reconstitution options and enable the self injection at home. But the likely the limitation on the volume is like a T to M L and uh you know,
the viscosity. You really cannot be very high because this normally require like a you know, uh the menu injection so and the other you know, more convenient uh uh technologies. Deliberate technologies will be like pre fiell syringe based and and if it is like you know, with a safety uh devices to go together, normally this is uh. The limitation will be you know, the on the volume and normally will below tom L and there are you know a few options above TWOML, but below like five IML.
I would say I would have concerts regarding the you know, the menu injection is especially for home care and also these a you know patient you know discomfort associated with this kind of a large volume injection and our injectors with the carriage or prey fill syringe is available as well.
And for like a very high volume, very high uh viscosity uh, this kind of formulation we have about it verse system available in recent years, we have a few commercialized per okay, yes, super and lindsay, yeah.
I agree.
I think the you know, the current kind of ideal scenario is that it's alone enof volume, Like we said, you typically find that it's like two mills for maybe a subcutaneous injection, and I think the challenge that we're facing is that with some of these products that require a higher dose, the volume either needs to be higher than that or you have to have a very high
concentration of your product. And with those high concentrations, you tend to run into those challenges where you not only have technical challenges during administration with high viscosity, but you can also have manufacturing challenges with those high viscosities as well. And so I think overcoming those challenges from the technical perspective will really be transformational for what we can do in the future.
Super great answers. So turning from what's today you know a parent and what we can use to perhaps what's on the horizon, Danny, I am keen to understand your perspective with respects to what do you see coming that's going to be really exciting in this field.
Yes, I'll split in two different technologies and some of the internal processes in the industry, some of the changes, and we're fortunate to have a lot of great example here at pub this week on the processes. I've been hearing a lot of the same team around formulation, packaging, device coming in together our early alignment with clinical and commercial to design the right product. To me that this is really exciting, you know, this is the early engagement, the time to start.
As far as.
Technology, usually with the help of some of the excipients, you can formally probably around one hundred and one fifty two hundred.
The most make PROMIL. Some of the new nano.
Micropowericles and polymer technology are helping us to push some of the boundaries up to four or five and maybe even six hundred MAKEPROMIL. So a lot of work to do to make sure here we form stable drug product in the end and it can be delivered properly.
But a lot of the exciting work in that film absolutely and e any thoughts on that too.
In the device technology area, so there were recent years development of a large volume of architectures, so large volume above two mL and below like five m L. There are so many A few device vendors also are presenting their technologies here in this conference and to overcome just inject volume larger than five amml or even like a you know, very viscous uh formulations. The body deliverer technologies
are you know on the horizon. Actually there are like two three commercialized products on the market already with one just withdraw recent today. So on body deliverse system has seems you know, provided the UH the most potential for large volume UH and from formulations UH the standpoint, there were so many new advanced formulation technologies are available in the development already.
So in the UH yesterday and today.
There are a few printations regarding the nanoparticles microsphere suspensions. So these you know, these are very very exciting and then you know quickly these formulation concentration can be like a double even like a triple from you know traditional formulation, right, so it can be even rich above neck six hundred milligrams per amal or a thousand mediagram per depending on the technology we are talking about. Another thing to U technology to enable these a large volume injection is that
that the enzyme development. So just an example, where would be like the HOLOGYM to improve the dissipation of the liquid in the subculteneous tissue and then in a very large bollets UH deliverery.
Yeah absolutely, obviously you know all these innovations, they're they're great. But with with with innovation comes challenges as well. So we have to really think technically, regulatory wise, and commercially how to address them to make sure that these innovations can to market for the benefit of patients. Final question really is around what's got the potential to completely disrupt
the future of drug delivery in the biologic space. You know, we see what's going on now, but what is the panacea in this space and what are the barriers that we need to overcome to enable this?
And perhaps lindsay if you could give your thoughts on.
This, sure, sure, And I think you just alluded to some of that as well. I think part it's really a combination of things that I think have to come together to really kind of overcome and transform how we can think about these high concentration, large volume products. I think there's definitely a formulation component to it, and what can we do with the formulation. Is there different excipients
we can think about using. You know, we have those eccipients that we've traditionally seen with our products, but how can we introduce new excipients into that market to help with some of those technical challenges. Combine that with things like modeling early on with different routes of administration and doing this all from an early stage can help us, you know, understand the combination of those things in product development so we can get them to a commercial state.
Super and Nick, you've got a lot of experience in consulting in this space and understanding the product development strategies around some of these types of products. What's your thoughts around what could disrupt in the future and how to overcome some of the barriers.
Yeah?
Sure, And I think first I've let's talk about some barriers, right. So at Kimbox, we obviously worked with quite a few companies. I don't know the exact number, but it's probably close to one hundred and fifty various pharma and advice companies. And I think some of the common themes that I see first of all is fear of risk.
Right.
I can't tell you in the last year how many times I've had a biologic sponsor come to us and say, Hey, we have this great new asset, we really need an injection system to use with it. We're going off the shelf. We're going as simple and as risk free as you possibly can. What can you give us, what can you help you know, what connections can you make for us?
And well that's great. I mean I understand, right.
The thought is we do not want to take additional risk during a complex biologic development program in order just to differentiate, because maybe the drug is supposedly the differentiator.
Right, does this drug work better.
Than anything else out there, Well, then you really don't need a custom autoinjector that has a different geometry than what's.
Already out there, because who cares, right.
The patient's more concerned about whether or not the drug works, and I think sometimes we really do forget about that.
A couple of years ago, I was working.
With a particular product and we did a patient research study and there was a gentleman who, in this particular.
Case had all sort of collitis that he.
Was asked various questions about different delivery systems and what his preferred autoinjector was, and he kind of he looked at the moderator and just responding pretty flat, lay, well, whichever one, whicheveryone delivers a drug that will stop me
from having to find a bathroom every ten minutes. And I thought that was it just kind of you know, I did a double take on it as well, because he's right, But I think is the product can the product be used, Yes, does the patient care about the real little minution that maybe the engineers care about?
Maybe not right? I think the second thing that I see.
Quite a bit is folks trying to solve a chemical problem by mechanical means. Right, So, Hey, we have this great new biologic, we need to formulate this at two hundred meg per mill We're going to deliver five mel tenml?
What can we possibly do here to deliver this product?
And sometimes I think they lose sight of what exactly are you trying to accomplish. Are you trying to go to more or less frequent dosing and that's why you're trying to deliver twenty AML of a biologic or tenml or whatever it is. And if that's the case, what is that duration? Is it once a month? Is it every two months? Is it every six months? Is it
once a year? Because I know there are some products that are in development or currently are on the market that are advertising once you get to a maintenance state, you're going to be delivering this product once a year. So from that perspective, even though maybe it's not the most patient centric or patient friendly option, what's against loading up ten mls into a syringe and putting it on a syringe pump and deliver that subque. They can do
that in a doctor's office. It's done once per year. Yes, it's not elegant, it's not glamorous, but it works. It gets a job done, and the patient burden going to an office once per year is really not that big of a burden. So that's kind of another consideration. And I guess finally, on the innovation side, and we've been talking about this a lot at this particular conference, is of course GLP one. Everyone wants to talk about GLP one.
So kind of like other things that happen in society, do you have a particular hot topic that then drives innovation in an associated space. So in this case, I don't have a crystal ball and tell you what some of the innovators in the GLP space will come up with next, but I would be shock if they did not drive innovation and new delivery technologies around a GOLP one molecule because there will be a push to differentiate
in that space. Patients will need different options versus what's out there, and especially as the molecules.
Themselves start to evolve and become more potent.
I think you're going to see a lot of different delivery systems that are introduced based on the funding that are off the revenue of these GOLP molecules, and whether that's formulation, chemistry, whether that's just a novel inter or i'm sorry, connected delivery device. Maybe it's taking a GOLP one merging with a device that then monitors patient adherence compliance. I know we have folks that love talking about connectivity,
but is connectivity of value? Well, in this case, if it's linked to an app that.
Then allows for a patient.
To be tracking their weight loss progress and motivates them to keep doing more and eventually weans them off a GLP one, maybe.
That's a great application for that type of technology.
So I think the future of all this, I think is I think it's gonna be on the back of the GLP want just because that's where the revenue is, and I think the company's doing it will want to innovate just to protect.
Their market share.
Absolutely great views there, Nick, and I think just to close and to wrap up, it's clear that there are some super exciting innovations in development soon to hit the market. Whilst we think we know what patients want, often patients don't actually realize what is possible.
And I'd like to.
Sort of, you know, ask you all to think back to Steve Jobs, right as somebody reminded me of this last night when I was at dinner gentlemen from Novnordisk, and he said, look, you know, Steve Jobs created the iPhone by putting lots of innovation together in a single device. But people at that time didn't realize that they wanted it. They didn't realize what was possible until they had it, and now people can't really do without it. And I think that's also something that we should think about when
it comes to drug delivery. Often, you know, we think we know what the patient wants, or perhaps we have perspective of what is required for patient centricity, but sometimes we need to go outside the box and think what could we do to make something that you know, nobody's ever thought of before. Let's try to push the boundaries of science and innovation. And I think that's why we're all here, that's why we're all invested, is to try and make better patient, better products for patients. So let's
continue to do that. Let's continue to innovate for the benefit of patients.
Thank you very much.
I think first of all those who are standing in the back of the room please come on forward. There's plenty of room up front. But I also first of all thank you to the panel. Maybe another round of applause for the panel, But we do have time for questions, and so i'd love for us again. You know, life is not a passive event. Please engage. Let's ask questions
of the panel and step forward. There's a microphone here, but I might ask the panel maybe to respond to something when we talk about balancing between concentration and volume.
The user population is.
Not homogeneous, right we have we have for example, pediatrics, right, we have different user populations. I wonder if the panel can perhaps respond to their thoughts around some of those particular opportunities, and maybe we can use pediatrics as a launch point or whatever whatever you would like to share.
To me at some point to understand the patient and the patient journey. Nick touch on some of the points around volume of injection and frequency of injection. Again, you know, it's ideal if you can design to the molecule, if you can add half life where they don't need you.
Know, as frequent dosing.
Sometimes you need different technology where you need to extend the half life. But it's really important to understand also from a sustainabilities timepoint and a reimbursement.
We haven't really touched on this.
These are all impotant factors and sometimes we're so focused on the device and the technical aspect. But maybe there's a different way to do it and getting to the doctor on a regular visit every three months, every six months, maybe the solution you know, doesn't need to be you know, as advanced. And for pediatrics, you know, we're not talking about self administration, so really important to understand your.
Patient, the caregiver or you know, how often they have to go visit their doctors.
Yeah, I agree, I think with considering a PDI presentation, I was in a meeting one day talking about pediatric presentations and you know, someone brought the perspective of being a parent and how often they if it's a product where they're going to have to administer their child, how often they would want to have to do that knowing that they have to hold down you know, maybe a very reluctant child to give them a dose of something that can't be that frequent, right, because that child is
not going to want to do that. So, you know, it's a it's a different consideration, but it's one that definitely has to be considered when you think about something like a pediatric population.
I can totally relate to that.
I took I took my daughter to to India and we had to go for a travel vaccine and it was two attempts at the doctor's you know, to actually get hurt, you know, to have the have the injections. So yeah, it's not not a nice situation. But I think we should consider those aspects.
I've been there.
It's great having to give your child a bear hug in the little clinic room at Walgreens because she needs a flu vaccine, right, but she won't hold still and they won't give it to her until she does.
So pries work really well.
I think there's another perspective also, you know, we think about, you know, the costs involved, right, we talked about the pay us uptake of patient centric medicines at the beginning, and but you know this, this was a good example of anxiety, right from a patient's perspective. But also you know, you think about patients perhaps are receiving oncology medicines, just having to go into that facility, having to see other
patients that are suffering right around them. That you can't really appreciate that unless you've been there and and and seeing the the the the anxiety that a patient might experience in that situation. If you can make those visits less frequent, if you can do more self administration at home, I think that's that's a huge, huge value that people people perhaps don't even perceive.
Well between the product for pediatric and for patients for adult patients, actually we may think they belong to the same product family, but actually these are two totally different products. We have to trade them, these two things, you know,
in different ways. So in termal for like you know, for basically those those those it's totally different, and user population can be a different, use condition can be different, so this may require a different device configuration to enable to accomplish all these two coveries to populations.
Just like to thank the panelists here and and yourselves for a great discussion.
Thank you.
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